Transcript: SOP010_05: Management of Investigational Products Info disclosed in professional context Anything that can identify someone Data security Physical – the location is protected Logical – authorization to access Data confidentiality ICF describes who has access and why No disclosure without consent! Any info on patients are recorded in ICF No study materials sent to sponsor contain identifiers Database archiving must meet local/national/international requirements refer to site archiving plan Export data, code lists, coding dictionaries, audit trails, edit check documentation, discrepancy management documentation and queries to long term storage media in an open format e.g. CSV files, XML, SAS, PDF, or Transport Files label should include archive date & how long media must be maintained Also archive test data in test databases Record hardware/software & versions used in Study Database Manual or Data Management Plan Record user history (+ user listings), all access rights & any changes (with authorization dates) Remove all necessary database access except for Administrator account that controls all user accounts Keep archived database + documentation in secure place with adequate backup copies Replicate media storage used to archive (for a working backup copy) Establish test schedule with regular intervals (i.e. every 5 years) to test that archived database is retrievable/loads/runs THE END Adverse drug reaction Adverse event Clinical trial Drug Good clinical practice Import Investigator’s brochure Protocol Qualified investigator Research ethics board Serious adverse drug reaction Serious unexpected adverse drug reaction Sponsor Abby Applicable to: personnel responsible for performing, reviewing, approving the recruitment/screening processes Use several recruitment methods throughout the study Develop recruitment materials to support recruitment efforts: Such as: advertisements, flyers, posters, internet ads, etc. Document the date that the informed consent form was signed The following documentation associated with Recruitment/Screening Activities must be retained: -Recruitment materials -Dated approval of the recruitment materials, from the REB as applicable -Recruitment/screening log (or equivalent) identifying subjects involved in the pre-study screening; this log should also include the reasons for pre-screening/screening failures -Subject enrollment log, listing enrolled subjects chronologically by study number -Subject identification code list, which permits the identification of all subjects who have taken part in the study (who were given a study number), in case follow-up of a subject is necessary ICF Revisions: Based on safety, amendments, REB/Health Canada recommendations Maintain a record of all REB communications REB Considerations: Obtain approval from the sponsor and REB before implementing any protocol/ICF amendment. Exception: emergency situation Study Subject Re-consent: When new information is available Standard Operating Procedures Inform Health Canada of SAE: Within 15 days for non-life-threatening SAE Within 7 days for life-threatening SAE Sponsor submits complete report in 8 days after informing HC Where possible, establish an electronic audit trail of all modifications and of additions to and deletions of entered data With respect to the interim release of data, it is important to maintain a record of the released datasets to include: -the data fields in the dataset as well as the date and time the dataset was created -the person to whom the data set was released -Whether or not the recoding of the treatment assignment was implemented “Source Document” = place where data are first recorded including: Hospital records Clinical & office charts Lab notes/reports CRF Memoranda Subjects’ diaries/evaluation checklists Pharmacy dispensing/accountability + storage records Recorded data from automated instruments Certified copies of transcriptions Microfiches and microfilm Photographic negatives Magnetic media X-rays Subject files Other medico-technical records Subjects incompetent to provide informed consent: A legally acceptable representative may consent on behalf of the subject ( ex. unconscious, severely ill, cognitively impaired) Subjects unable to read: Impartial witness must be present during the informed consent discussion Obtain verbal consent after the ICF is read Obtain signatures from the subject and the witness Subjects unable to speak English: The informed consent discussion must take place in the subject’s first/preferred language using a interpreter C.05.05 Application for Authorization SOP014_5 Clinical Data Management Preparing for Close-Out & Monitor Visit SOP014_5 Clinical Data Management Informed consent before study enrollment: Person obtaining consent is qualified and knowledgeable Review study details Assess the subject’s competence to consent to research Give the subject ample time to read the ICF/other information Ask the subject questions to assess their comprehension
Transcript: Software's are important because people have to rely on software's to protect their documents on a laptop or major business companies have to use these software's to keep all the company records on. Some software developers might make the code available to other developers because it could help other applications in the market. Manufacturers may want to buy a software to further enhance their application. 1) How long the software can be used for. 2) The conditions of what the software is to be used for. 3) The support of the the software like the updates of upgrades. 4) Cost of the rights to use the software. 5) The warranty if there is one, 6) Liability of each party for damages that results from the consumers use of the software. 7) Ownership rights of the software for any products or applications made using the software. 8) If any disputes were need resolving. 9) User's rights to gain access to the source code. 10) Any other issues important to the parties What Are Software Licenses? How Does The Software Agreement Work? Software Licensing Luke Walden The creator of the software code normally owns the code, and the owner normally gets to control who is allowed to the use the code and the circumstances in which the code can be used. Something called (end user license agreements) EULAs, are normally use for software's that are used on a mass base so when the consumer of the software buys it they have to agree to terms and licenses for example: Microsoft word & ios use this. So really they aren't buying the software they are actually just licensing it. What Can A Software License Cover? One of the main issues in software licensing is that who actually owns the software that is developed for the consumer. The attorney helps so that large amounts of money is the spent on what the the software developer is not allowed to license or the consumer doesn't get the right to use the software. The attorney can help the consumer avoid unwanted or uninsured liability. The attorney can help the client in developing audit procedures to comply with terms of an existing or proposed software license.The attorney can aid a consumer to identify how the software will be used and using that information notify the customer on legal issues that can happen in developing, sharing and using software for the appropriate purposes. Why Are They Important? Software licenses are agreements between companies or people which will allow other people than the company to use that software code. How Can An Attorney Help With The Licensing Of The Product?
Transcript: Presented by Luya Business Our Company New doc, $, TXL Shipper General procedure Agent Our team Name Title Name, Title Name Title Name, Title Name Title Name, Title Shipping company Offering Company List Company List APL Evergreen Zim MSC CM Solution Solution Competitive Advantages Competitive Advantages Company List Truck company Case Study Before After Warehouse Cnee Q A & Broker
Transcript: Development & Validation Web Based Visual & Photo Based Approval and Role out Process Approval Tracking Field Involvement SOP Conformance Support Training Safety Hazard Recognition Mobility Development Tool Safe Operating Procedures Use of Icons Success Systemic Format A complete System Roll Out Tracking
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Transcript: Statement of Purpose What I bring to the table -Prolific Blogger www.wackoxl.blogspot.in www.19anjanspeaks.blogspot.com Agenda for ExLink A sneak peek -Editor of college magazine REFLECTIONS -Published articles in JAM Mag (Rashmi Bansal's e-student magazine) ExLink -Pen down short stories (MyNotes in FB) ANJAN MAHAPATRA -Content Writer for Oyeweekend.com #JokarHunters Series Posts for www.xlmerijaan.com Bishu Da & We wont give it back Part-1 Articles for SAMHITA, the Monthly Magazine of Fire@ax Articles for the annual newsletter of AlComm Articles for MAGIS, ExLink Articles for MyNewsstudio.com Senior Executive Member XLRI
Transcript: Sophie Germain's greatest contribution to mathematics was in number theory. She discovered a special case of Fermat's Last Theorem which we now call the Germain Theorem. Stated precisely: The equation x p +y p =z p has no non-zero integer solutions where p is a Germain prime (p is a prime number if 2p+1 is also prime) and p does not divide xyz . Could someone prove this? I can't find an actual proof of this statement or Germain's surviving works in English translation. Contribution 2 intro to mathetics Sophie Germain by Shelby Sweet When Germain was 13, the Bastille fell, and the revolutionary atmosphere of the city forced her to stay inside. For entertainment she turned to her father's library. Here she found J. E. Montucla's L'Histoire des Mathématiques, and his story of the death of Archimedes intrigued her. Germain decided that if geometry, which at that time referred to all of pure mathematics, could hold such fascination for Archimedes, it was a subject worthy of study. So she pored over every book on mathematics in her father's library, even teaching herself Latin and Greek so she could read works like those of Sir Isaac Newton and Leonhard Euler. She also enjoyed Traité d'Arithmétique by Étienne Bézout and Le Calcul Différentiel by Jacques Antoine-Joseph Cousin. Later, Cousin visited her in her house, encouraging her in her studies. Germain's parents did not at all approve of her sudden fascination with mathematics, which was then thought inappropriate for a woman. When night came, they would deny her warm clothes and a fire for her bedroom to try to keep her from studying, but after they left she would take out candles, wrap herself in quilts and do mathematics. As UC Irvine's Women's Studies professor Lynn Osen describes, when her parents found Sophie “asleep at her desk in the morning, the ink frozen in the ink horn and her slate covered with calculations,” they realized that their daughter was serious and relented. After some time, her mother even secretly supported her. Contribution 1 Conclusion Contribution 3 Perhaps only a lone genius like Germain was constituted to thrive in such isolation, leaving her work of pure intellection like a beacon to later generations of women who dared to do mathematics for the joy of it. When Sophie began teaching herself, her parents took away her books. So she studied secretly at night. INTRODUCTION She also contributed to acoustics, Eric Weisstein's World of Physics elasticity, Eric Weisstein's World of Physics and number theory. Eric Weisstein's World of Math She submitted a memoir to the mathematician J. L. Lagrange under a male student's name. Lagrange saw talent in the work, sought out the author, and was bowled over to discover it had been written by a woman. She continued to study, corresponding with leading mathematicians of the day. Sophie Germain was a French mathematitian, physicist, and philosopher. She was born on April 1, 1776, and passed June 27,1831 at the age of 55.
Transcript: Safeguard the information in Systems. Reduce business and legal risk. Protect the good name of the STC. Ensure that IT solutions are cost-effective and used optimally to bring true benefit to Save the Children. Software Passwords will expire every 90 days and you will be notified. To reset your password use the password portal: https://sciad.savethechildren.org/admanagerweb After you change your password, sign in with new password. The password portal can be used at anytime to change your password. Any previous email account .pst file attach to your new outlook SCI email account. Data Backup Home Drive System Access Degrade the speed. Via video and audio the network become congested and official emails become down. Any other messengers are not allowed to be installed on any machine.(Prohibited). Users wishing to use Skype or other VoIP software should consult the in-country IT representative to confirm whether their office’s Internet connection can support it. Save the Children is committed to only using licensed software on its IT systems and equipment. Save the Children reserves the right to take disciplinary action against anyone found breaching copyright law, which may lead to dismissal in serious cases. Save the Children is committed to only using licensed software on its IT systems and equipment Thanks Any Questions ???? Information Technology DepartmentSave the Children Use of messengers (Skype). Finally Information Technology Structure in Islamabad The key objective of Data Backup is to put a duplicate copy of Files . If any serious damage occur so that we can recover our original data. Data backup can be done on regular basis. (CD/DVD, Server ,External hard drive). Network Drive (Z Drive). Avoid save your data on Desktop. Prevention is always better cure. Keeping the Data importance and confidentiality a network Drive is introduce for your convenience & protection of Data. This Drive is known as “Home Drive”. Initially its storage limit is up to 2GB. Save the Children Policy Users should not allow any person access to the Save the Children IT equipment they are using, unless that person is the authorized system administrator. The confidentiality and integrity of data stored on Save the Children’s computer systems must be protected by controls allowing only authorized users to have access. Users must not attempt to alter software or hardware configurations, or attempt to gain access to another user’s data, e-mail, other electronic or telephonic communications, without authorization. Email operation
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